NCT01618526

Brief Summary

Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon. In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are randomized to two types of diet intervention: a low and a high fiber diet. The participants are subjected to endoscopy before and in the end of each intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

August 1, 2013

Enrollment Period

1.7 years

First QC Date

May 30, 2012

Last Update Submit

May 28, 2015

Conditions

Metabolic Syndrome

Keywords

Dietary fibersButyrateShort Chain Fatty AcidsColonMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Feces-short chain fatty acids

    Concentration of short chain fatty acids

    Baseline and 4 weeks

Secondary Outcomes (5)

  • A change in gut microbiome evaluated by 16 S-RNA analysis

    Baseline and 4 weeks

  • Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis.

    Baseline and 4 weeks

  • Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17).

    Baseline and 4 weeks

  • Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β).

    Baseline and 4 weeks

  • Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.

    Baseline and 4 weeks

Study Arms (2)

Healthy Carbohydrate Diet

ACTIVE COMPARATOR

4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch

Dietary Supplement: Healthy Carbohydrate Diet

Western Style Diet

PLACEBO COMPARATOR

4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans.

Dietary Supplement: Western Style Diet

Interventions

Western Style DietDIETARY_SUPPLEMENT

Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers (Arabinoxylans and Resist Starch) compared with a Western Style Diet with a low content of dietary fibers.

Western Style Diet
Healthy Carbohydrate DietDIETARY_SUPPLEMENT

Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers ( Arabinoxylans and Resistent Starch) compared with Western Style Diet with low content of dietary fibers

Healthy Carbohydrate Diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Central obesity (Female \> 80 cm, Male \> 94 cm)
  • HDL cholesterol (Female \< 1,03 mmol/L, Male \< 1,29 mmol/L)
  • Bloodpressure (\> 130/85 mmHg)
  • Fasting Blood Glucose \> 5,6 mmol/L

You may not qualify if:

  • Diabetes
  • Gastrointestinal disease
  • Serious liver, heart or kidney disease
  • Anticoagulation treatment
  • Anaemia
  • Corticosteroid treatment
  • Waist circumference above 130 cm
  • Alcohol or drug addiction
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Hald S, Schioldan AG, Moore ME, Dige A, Laerke HN, Agnholt J, Bach Knudsen KE, Hermansen K, Marco ML, Gregersen S, Dahlerup JF. Effects of Arabinoxylan and Resistant Starch on Intestinal Microbiota and Short-Chain Fatty Acids in Subjects with Metabolic Syndrome: A Randomised Crossover Study. PLoS One. 2016 Jul 19;11(7):e0159223. doi: 10.1371/journal.pone.0159223. eCollection 2016.

    PMID: 27434092DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Knud Erik Bach Knudsen, Professor

    Aarhus University, Department of Animal Sciens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 13, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

May 1, 2015

Last Updated

May 29, 2015

Record last verified: 2013-08

Locations

DK(1)